Available data suggest that NITs can predict clinical outcomes and help accelerate clinical development and bring a safe and efficacious therapy to NASH patients with high unmet need.
TORONTO (PRWEB)
October 12, 2022
Diagnosing and assessing the progression of nonalcoholic steatohepatitis (NASH) continue to be some of the most challenging aspects of its management. Most patients would opt out of the diagnostic or follow-up liver biopsy. Also, liver biopsies would not be a front-line test offered by primary care physicians, endocrinologists and diabetologists where a large proportion of undiagnosed patients exist. In addition, recent clinical trial data has shown considerable variability in histopathology readings, making it unreliable for use in clinical trials.
A better approach is needed. Over the last 10 years, there has been increasing interest in the development and validation of non-invasive tests (NITs) that can diagnose NASH, stratify risk, predict clinical outcomes and/or monitor the progression or regression of the disease. NITs may also help to identify NASH sub-phenotypes with potential distinct natural history and prognosis and eventually, facilitate personalized treatment and better response rate. Finally, available data suggest that NITs can predict clinical outcomes and help accelerate clinical development and bring a safe and efficacious therapy to NASH patients with high unmet need.
Currently, many different imaging and blood-based NITs are being explored in clinical trials. In some trials, pre-biopsy enrichment strategies with NITs are becoming increasingly popular to reduce the number of liver biopsy-related screen failures. These NITs include genetic susceptibility alleles, specific protein biomarkers and multi-analyte algorithms. Sorting through these NITs, their use individually and in combination, admittedly requires some navigational assistance.
Register to learn how non-invasive biomarkers are driving a paradigm shift in NASH clinical trials and clinical care.
Join experts from Labcorp Drug Development, Claudia Filozof, MD, PhD, Vice President, Liver Therapeutic Area; Katherine T. Landschulz, PhD, Senior Director, Therapeutic Area Lead, Biomarker Solution Center; Lara Dimick-Santos, MD, Executive Medical Director, CVMER; and Margery A. Connelly, PhD, MBA, FAHA, Strategic Director, Diagnostics R&D, for the live webinar on Thursday, October 27, 2022, at 10:30am EDT (3:30pm BST/UK).
For more information, or to register for this event, visit Time for Change in NASH: How Non-Invasive Biomarkers are Driving a Paradigm Shift in Clinical Trials and Clinical Care.
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